Active ingredient
Odevixibat
8 finished FDA listings contain Odevixibat as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ODEVIXIBAT, ODEVIXIBAT SESQUIHYDRATE
- Dosage forms
- Capsule, Capsule, Coated Pellets
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 1200 ug/1 · 200 ug/1 · 400 ug/1 · 600 ug/1
- Brand names in FDA listings
- Bylvay
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2563966
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 215498 | IPSEN | 2021-07-20 | 8 |
Official labeling on DailyMed
- BYLVAY (ODEVIXIBAT) CAPSULE, COATED PELLETS [ALBIREO PHARMA, INC.] · version 10 · 2026-09-04
- BYLVAY (ODEVIXIBAT) CAPSULE, COATED PELLETS BYLVAY (ODEVIXIBAT) CAPSULE [IPSEN BIOPHARMACEUTICALS, INC.] · version 4 · 2025-12-31
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.